Aline Ablation Intelligence
510(k) K202297
Aline Ablation Intelligence is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Mirada Medical, Ltd., cleared under FDA 510(k) K202297 on 11 Sep 2020, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK202297 | Date11 Sep 2020 | StatusActive |
Official records
- FDA 510(k) database K202297
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K202297
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Aline Ablation Intelligence 1.0 | 1.0 | B334ALINE1P00 | — | On the market |
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